Compliant • GDPR • HIPAA • ISO 13485 • Certifications

To help our biopharma and medtech customers with compliance and reporting, we share information, best practices, and easy access to documentation. Our BrightInsight Platform regularly undergoes independent verification of security, privacy, and compliance controls, achieving certifications against global standards to earn your trust. We’re constantly working to expand our coverage.

CE Mark

The CE mark appears on products in the EU to affirm that they comply with applicable EU regulations.

EU Medical Device Regulation (MDR)

A regulation that governs the production and distribution of medical devices in Europe

IEC 82304-1

Health software – Part 1: General requirements for product safety.

Medical Device Single Audit Program (MDSAP)

Single regulatory audit of a medical device manufacturer to satisfy the relevant requirements of the regulatory authorities in the U.S., Canada, Japan, Brazil and Australia.